Protonix

Pronunciation

Generic Name: Pantoprazole Sodium
Class: Proton-pump Inhibitors
VA Class: GA900
Chemical Name: 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole
CAS Number: 164579-32-2

Warning(s)

Special Alerts:

[Posted 02/08/2012] ISSUE: FDA notified the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve. The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.

FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers. H2 receptor blockers are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and heartburn.

BACKGROUND: Proton pump inhibitors (PPIs) are marketed under various brand and generic drug names as prescription and over-the-counter (OTC) products. They work by reducing the amount of acid in the stomach. Prescription PPIs are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Over-the-counter PPIs are used to treat frequent heartburn.

Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea that does not improve. Symptoms include watery stool, abdominal pain, and fever, and patients may go on to develop more serious intestinal conditions. The disease can also be spread in hospitals.

RECOMMENDATION: Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve. Information for Healthcare Professionals:

  • A diagnosis of CDAD should be considered for PPI users with diarrhea that does not improve.

  • Advise patients to seek immediate care from a healthcare professional if they experience watery stool that does not go away, abdominal pain, and fever while taking PPIs.

  • Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

For more information visit the FDA website at: and .

Introduction

Acid- or proton-pump inhibitor; gastric antisecretory agent.1 2 3 4 5 6 7 8 10

Uses for Protonix

Gastroesophageal Reflux (GERD)

Orally for short-term treatment of erosive esophagitis in patients with GERD.1

Orally to maintain healing and decrease recurrence of erosive esophagitis.1

IV for up to 7–10 days in the treatment of GERD in patients with a history of erosive esophagitis.10 Discontinue IV therapy as soon as patient is able to initiate or resume oral therapy with the drug.10

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Pathologic GI Hypersecretory Conditions

Orally for long-term treatment of pathologic hypersecretory conditions, including Zollinger-Ellison syndrome.1

IV for up to 6 days in the treatment of pathologic hypersecretory conditions associated with Zollinger-Ellison syndrome or other neoplastic conditions.10

Duodenal Ulcer

Orally for treatment of duodenal ulcer.2 3 5 6 8

Gastric Ulcer

Orally for treatment of gastric ulcer.2 3 5 6 8

Crohn’s Disease-associated Ulcers

Some evidence for use of proton-pump inhibitors (e.g., omeprazole) for gastric acid suppressive therapy as an adjunct in the management of upper GI Crohn’s disease, including esophageal, gastroduodenal, and jejunoileal disease.18 19 20 21 22 23 24

Protonix Dosage and Administration

Administration

Administer orally or IV.1 10 Administer once daily for GERD.1 10 Generally given twice daily for pathologic GI hypersecretory conditions, although may be administered IV every 8 hours if necessary.1 10

Oral Administration

Delayed-release Tablets

Administer delayed-release tablets without regard to meals.1

Antacids may be used concomitantly.1

Swallow tablets whole; do not split, crush, or chew.1 May administer two 20-mg tablets if unable to swallow a 40-mg tablet.1

Delayed-release Oral Suspension

Administer delayed-release oral suspension 30 minutes before a meal.1

Mix delayed-release granules for oral suspension with applesauce or apple juice; do not mix with any other foods or liquids (including water).1

Sprinkle the contents of a single-dose packet of pantoprazole sodium delayed-release granules for oral suspension onto 1 teaspoonful of applesauce and administer within 10 minutes of preparation.1

Alternatively, sprinkle the packet contents into 5 mL of apple juice, stir for 5 seconds, and swallow the resulting suspension immediately.1 Rinse the container once or twice with apple juice; swallow the rinsings immediately to ensure complete delivery of the dose.1

Swallow granules in the oral suspension intact; do not crush or chew the granules.1

NG Tube

May administer pantoprazole sodium delayed-release granules for oral suspension via a nasogastric tube (16 French or larger).1

Remove the plunger from a 60-mL syringe and attach the catheter tip of the syringe to the NG tube.1 Empty the contents of a single-dose packet of the granules into the syringe barrel while holding the syringe as high as possible to prevent bending of the tubing.1 Add 10 mL of apple juice to the syringe; gently tap or shake the syringe to facilitate emptying.1 Rinse the syringe and tubing with 10 mL of apple juice at least 2 more times (until no granules remain).1 Verify patency of the tubing to ensure complete delivery of the dose.1

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer through a dedicated IV line or a Y-site.10

Use of spiked IV system adapters may result in breakage of the glass vial, and currently is not recommended by the manufacturer.14 15 (See Glass Vial Breakage under Cautions.)

Administer as reconstituted solution or following further dilution.10

Reconstitution

Reconstitute vial containing 40 mg pantoprazole with 10 mL of 0.9% sodium chloride injection to provide a solution containing 4 mg/mL.10

Dilution

GERD: Dilute one vial of reconstituted solution containing pantoprazole 4 mg/mL with 100 mL of 5% dextrose injection, 0.9% sodium chloride injection, or lactated Ringer’s injection to produce a concentration of about 0.4 mg/mL.10

Pathologic hypersecretory conditions: Dilute 2 vials of reconstituted solution containing pantoprazole 4 mg/mL with 80 mL of 5% dextrose injection, 0.9% sodium chloride injection, or lactated Ringer’s injection to produce a concentration of 0.8 mg/mL.10

Rate of Administration

GERD: Administer 40-mg dose IV as the reconstituted (4 mg/mL) solution over not less than 2 minutes10 or as the 0.4-mg/mL dilution over about 15 minutes (7 mL/minute).10

Pathologic hypersecretory conditions: Administer 80-mg dose IV as the reconstituted (4 mg/mL) solution over not less than 2 minutes10 or as the 0.8-mg/mL dilution over about 15 minutes (7 mL/minute).10

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as pantoprazole sodium; dosage expressed in terms of pantoprazole.1 10

Adults

GERD
IV

40 mg once daily for 7–10 days.10 Discontinue IV therapy when patient is able to initiate or resume oral therapy; safety and efficacy of IV therapy for >10 days not established.10

Treatment of Erosive Esophagitis
Oral

40 mg once daily for up to 8 weeks.1 2 If not healed, consider additional 8 weeks of therapy.1 2

Maintenance of Healing of Erosive Esophagitis
Oral

40 mg once daily.1 Not studied for >1 year of therapy.1 However, chronic, lifelong therapy with proton-pump inhibitor may be appropriate.12

Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome)
Oral

40 mg twice daily.1 Adjust dosage according to patient response and tolerance; continue therapy as long as necessary.1 May require dosages of up to 240 mg daily.1 Patients with Zollinger-Ellison syndrome have been treated for >2 years.1

IV

80 mg every 12 hours.10 80 mg every 8 hours is expected to maintain acid output <10 mEq/hour in patients requiring higher dosage.10 Safety and efficacy of dosages exceeding 240 mg daily or use of IV pantoprazole for >6 days not established.10

Special Populations

Hepatic Impairment

No dosage adjustment necessary.1 2 3 4 10 Dosage exceeding 40 mg daily not studied in patients with hepatic impairment.1 10

Cautions for Protonix

Contraindications

  • Known hypersensitivity to pantoprazole, any ingredient in the formulation, or to other substituted benzimidazoles (e.g., esomeprazole, lansoprazole, omeprazole, rabeprazole).1 10 16

Warnings/Precautions

Sensitivity Reactions

Anaphylaxis

Anaphylaxis reported with IV pantoprazole.10 Immediately discontinue drug and institute appropriate medical intervention.10

General Precautions

GI Effects

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Response to pantoprazole does not preclude presence of occult gastric neoplasm.1 10

Atrophic gastritis reported occasionally with long-term pantoprazole use, especially in patients infected with Helicobacter pylori.1

Glass Vial Breakage

Breakage of pantoprazole vials reported during attempts to connect the vials to spiked IV system adapters.14 15 Potential safety issue for health-care professionals attempting to connect these system components manually or with mechanical assistance.14 15 Pantoprazole manufacturer does not recommend use of spiked IV system adapters; if such adapters are used, contact manufacturer of the adapter for assistance.14

Injection Site Reactions

Injection site reactions (e.g., thrombophlebitis, abscess) associated with use of IV pantoprazole.10

Hepatic Effects

Mild, transient elevations of serum ALT reported with oral therapy; 0.4% incidence of serum ALT increases >3 times the upper limit of normal with pantoprazole dosage of 40 mg daily in short-term studies.1 10

Edetate Disodium Content

Pantoprazole sodium for injection contains edetate disodium (disodium EDTA), a potent metal ion (e.g., zinc) chelator.10 Consider zinc supplementation in patients prone to zinc deficiency.10 Use caution with other IV products that contain edetate disodium.10

Cyanocobalamin Malabsorption

Deficiency due to malabsorption from prolonged (e.g., >3 years) gastric acid suppression reported rarely.1 Consider possibility if manifestations of cyanocobalamin deficiency occur.1

Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).25 26

Bone Fracture

Several observational studies suggest that use of proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., ≥1 year), may be associated with increased risk of osteoporosis-related fractures of the hip, wrist, or spine.27 300 301 302 303 304 305 309 Magnitude of risk is unclear;27 300 301 302 303 304 305 310 causality not established.305 FDA is continuing to evaluate this safety concern.305

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient’s clinical condition.27 301 303 305 307 309

Individuals at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D; assess and manage these patients’ bone health according to current standards of care.27 303 305 307 309

Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, reported rarely in patients receiving long-term therapy (≥3 months or, in most cases, >1 year) with proton-pump inhibitors, including pantoprazole.309 317 318 319 320 321 322 323 324 325 326 327 328 329 330 Serious adverse effects include tetany, seizures, tremors, carpopedal spasm, arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia), and abnormal QT interval.309 318 319 321 322 323 325 327 328 329 Paresthesia, muscle weakness, muscle cramps, lethargy, fatigue, and unsteadiness may occur.319 320 321 325 330 Most patients required magnesium replacement and discontinuance of the proton-pump inhibitor.309 317 319 321 322 323 324 325 326 327 330 Hypomagnesemia resolved within 1 week (median) following discontinuance and recurred within 2 weeks (median) of rechallenge.327

In patients expected to receive long-term proton-pump inhibitor therapy or in patients currently receiving digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), consider measuring serum magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter.309 319 326 327 328 330

Specific Populations

Pregnancy

Category B.1 10

Lactation

Distributed into milk.1 10 Discontinue nursing or the drug because of potential risk in nursing infants.1 10

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 9 10

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1 10

Common Adverse Effects

Oral: Short-term (up to 8 weeks): Headache,1 diarrhea,1 flatulence,1 abdominal pain,1 rash,1 eructation,1 insomnia,1 hyperglycemia.1 Long-term (up to 12 months): Headache,1 abdominal pain,1 nausea,1 vomiting,1 abnormal liver function test results.1

IV: abdominal pain,10 headache,10 injection site reaction (e.g., thrombophlebitis, abscess),10 constipation,10 dyspepsia,10 nausea,10 diarrhea,10 insomnia,10 dizziness,10 rhinitis.10

Interactions for Protonix

Extensively metabolized, principally by CYP2C19 and to a minor extent by CYP3A4, 2D6, and 2C9.1 10

Drugs Metabolized by Hepatic Microsomal Enzymes

Unlikely to have clinically important interaction with drugs metabolized by CYP2C19, 3A4, 2D6, 2C9, 1A2.1 10

Drugs that Cause Hypomagnesemia

Potential pharmacologic interaction (possible increased risk of hypomagnesemia).327 Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter.309 327 (See Hypomagnesemia under Cautions.)

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Alcohol

Pharmacokinetic interaction unlikely1 10

Amoxicillin

Pharmacokinetic interaction unlikely1 10

Antacids

No clinically important effects on oral pantoprazole absorption1

May be used concomitantly1

Antipyrine

Pharmacokinetic interaction unlikely1 10

Atazanavir

Possible altered oral absorption of atazanavir, resulting in decreased plasma atazanavir concentrations; possible loss of virologic response1 10 30

Manufacturer of pantoprazole states that concomitant administration with atazanavir is not recommended1 10

Antiretroviral treatment-naive patients: If a proton-pump inhibitor is used concomitantly with atazanavir, administer ritonavir-boosted atazanavir (atazanavir 300 mg and ritonavir 100 mg once daily with food); administer the proton-pump inhibitor approximately 12 hours before ritonavir-boosted atazanavir29 30

For treatment-naive patients, dosage of proton-pump inhibitor should not exceed omeprazole 20 mg daily (or equivalent)29 30

Antiretroviral treatment-experienced patients: Concomitant use of proton-pump inhibitors with atazanavir not recommended29 30

Caffeine

Pharmacokinetic interaction unlikely1 10

Carbamazepine

Pharmacokinetic interaction unlikely1 10

Cisapride

Pharmacokinetic interaction unlikely1 10

Clarithromycin

Pharmacokinetic interaction unlikely1 10

Clopidogrel

Certain CYP2C19 inhibitors (e.g., omeprazole) reduce exposure to clopidogrel’s active metabolite and decrease platelet inhibitory effects; potentially may reduce clopidogrel’s clinical efficacy.35 224 225 228 311

Extent to which other proton-pump inhibitors (which may differ in CYP2C19-inhibitory potency) may interfere with clopidogrel’s effects is unknown31 32 33 224 232

Assess risks and benefits of concomitant proton-pump inhibitor and clopidogrel use in individual patients237 240 243 248 250

American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that GI bleeding risk reduction with concomitant proton-pump inhibitor in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or NSAIAs; H. pylori infection) may outweigh potential reduction in cardiovascular efficacy of antiplatelet treatment associated with a drug–drug interaction.311 In patients without such risk factors, ACCF/ACG/AHA states that risk/benefit balance may favor use of antiplatelet therapy without a proton-pump inhibitor.311

If concomitant therapy with a proton-pump inhibitor and clopidogrel is considered necessary, some clinicians prefer pantoprazole (which appears to be the weakest CYP2C19 inhibitor among proton-pump inhibitors)35 36 230 alternatively, consider use of a histamine H2-receptor antagonist (ranitidine, famotidine, nizatidine)35 36 230 but not cimetidine (also a potent CYP2C19 inhibitor)224 232 233

Diazepam

Pharmacokinetic interaction unlikely1 10

Diclofenac

Pharmacokinetic interaction unlikely1 10

Digoxin

Pharmacokinetic interaction unlikely1 10

Hypomagnesemia (e.g., resulting from long-term use of proton-pump inhibitors) sensitizes the myocardium to digoxin and, thus, may increase risk of digoxin-induced cardiotoxic effects327 331

Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter309 327

Diuretics (i.e., loop or thiazide diuretics)

Possible increased risk of hypomagnesemia327

Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter309 327

Gastric pH-dependent drugs (e.g., ampicillin esters, iron salts, ketoconazole)

Pantoprazole may decrease drug absorption1 10

Glyburide

Pharmacokinetic interaction unlikely1 10

Metoprolol

Pharmacokinetic interaction unlikely1 10

Metronidazole

Pharmacokinetic interaction unlikely1 10

Midazolam

Pharmacokinetic interaction unlikely1 10

Naproxen

Pharmacokinetic interaction unlikely1 10

Nifedipine

Pharmacokinetic interaction unlikely1 10

Oral contraceptives (e.g., levonorgestrel/ethinyl estradiol)

Pharmacokinetic interaction unlikely1 10

Phenytoin

Pharmacokinetic interaction unlikely1 10

Piroxicam

Pharmacokinetic interaction unlikely1 10

Sucralfate

Possible delayed proton-pump inhibitor absorption and decreased bioavailability17

Administer proton-pump inhibitor at least 30 minutes before sucralfate17

Tests for tetrahydrocannabinol (THC)

Possible false-positive results for urine screening tests for THC1 10

Use alternative confirmatory test for verification of positive results1 10

Theophylline

Pharmacokinetic interaction unlikely1 10

Warfarin

Potential increased INR and PT1 10 17

Monitor for INR and PT increases1 10 17

Protonix Pharmacokinetics

Absorption

Bioavailability

Well absorbed from GI tract (absolute bioavailability about 77%).1 Peak plasma concentrations attained about 2.5 hours after single or multiple 40-mg oral doses (as delayed-release tablets).1 Time to peak concentration is similar (2–2.5 hours) for delayed-release suspension administered orally or via NG tube.1

Administration of delayed-release oral suspension (in apple juice) via NG tube is bioequivalent to oral administration of the same formulation (in applesauce or apple juice).1 Delayed-release suspension is comparable to delayed-release tablets in degree of inhibition of pentagastrin-stimulated gastric acid secretion.1

Onset

51% mean inhibition of gastric acid secretion within 2.5 hours after a single 40-mg oral dose; 85% after daily administration for 7 days.1

15–30 minutes after single 20- to 120-mg IV infusion.10 About 96% suppression of pentagastrin-stimulated acid output within 2 hours after 80-mg IV infusion.10

Duration

Acid secretion normalized within one week after discontinuance of oral pantoprazole; no apparent rebound hypersecretion.1

24 hours after single IV infusion.10 Median percentage of time gastric pH ≥4 similar after 40 mg IV or orally daily for 5 days.10

Food

Food delays absorption of delayed-release tablets but does not affect extent or peak plasma concentrations.1

Special Populations

Pharmacokinetics in patients with severe renal impairment similar to healthy individuals.1 10

Peak plasma concentrations and AUCs increased in patients with mild to severe hepatic impairment, but no more than in slow metabolizers.1 10 (See Hepatic Impairment under Dosage and Administration.)

Distribution

Extent

Mainly extracellular.1 10 Prolonged binding to gastric parietal proton pump enzyme.1 10

Distributed into milk.1 10

Plasma Protein Binding

98%, principally albumin.1 10

Elimination

Metabolism

Metabolized in the liver, principally by CYP2C19, and to a lesser extent by CYP3A4.1 10 Metabolites appear to be inactive.1 10

Elimination Route

Excreted in urine (about 71%) and feces (18%); no unchanged drug excreted in urine.1 10

Half-life

1 hour.1 10

Special Populations

Hepatic impairment increased plasma half-life to 7–9 hours, but no more than in slow metabolizers, and minimal accumulation occurs.1 10

In patients with poor CYP2C19 metabolizer phenotype, metabolism is slower than those with extensive (or rapid) metabolizer phenotype; elimination half-life is 3.5–10 hours, but minimal accumulation occurs.1 10

Not removed by hemodialysis.1 10

Stability

Storage

Oral

Delayed-release Tablets

20–25°C (may be exposed to 15–30°C).1

Granules for Delayed-release Suspension

20–25°C (may be exposed to 15–30°C).1

Parenteral

Powder for Injection

20–25°C (may be exposed to 15–30°C).10 Protect from light.10

Store reconstituted (4 mg/mL) solution at room temperature for up to 24 hours prior to administration as 4-mg/mL solution.10 If reconstituted solution will be further diluted, store reconstituted solution for up to 6 hours before dilution; then store diluted (0.4 or 0.8 mg/mL) solution at room temperature and use within 24 hours of initial reconstitution.10 Do not freeze reconstituted solution.10 Not necessary to protect reconstituted or diluted solution from light.10

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible

Dextrose 5% in water

Sodium chloride 0.9%

Drug Compatibility
Y-Site CompatibilityHID

Compatible

Ampicillin sodium

Anidulafungin

Cefazolin sodium

Ceftriaxone sodium

Dimenhydrinate

Dopamine HCl

Epinephrine HCl

Furosemide

Morphine sulfate

Nitroglycerin

Potassium chloride

Vasopressin

Incompatible

Dobutamine HCl

Esmolol HCl

Mannitol

Midazolam HCl

Multivitamins

Variable

Norepinephrine bitartrate

Octreotide acetate

Manufacturer states that pantoprazole sodium may be incompatible with zinc-containing preparations.10

Actions

  • Inhibits basal and stimulated gastric acid secretion.1 10

  • Concentrates in acid conditions of parietal cell secretory canaliculi; forms active sulfenamide metabolite that irreversibly binds to and inactivates hydrogen-potassium ATPase (proton- or acid pump), blocking final step in secretion of hydrochloric acid.1 2 3 4 5 6 7 8 9 10 Acid secretion is inhibited until additional hydrogen-potassium ATPase is synthesized, resulting in prolonged duration of action.1 2 3 4 5 6 7 8 9 10

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Importance of swallowing tablets whole, without splitting, crushing, or chewing.1

  • Delayed-release tablets may be administered without regard to meals.1

  • Importance of taking delayed-release suspension 30 minutes before a meal.1

  • Importance of instructing patients regarding proper preparation and administration of the oral suspension.1

  • Importance of advising patients that use of multiple daily doses of the drug for an extended period of time may increase the risk of fractures of the hip, wrist, or spine.305 309

  • Risk of hypomagnesemia; importance of immediately reporting and seeking care for any cardiovascular or neurologic manifestations (e.g., palpitations, dizziness, seizures, tetany).309

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 10 Antacids may be used concomitantly with delayed-release tablets.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 10

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Pantoprazole Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For suspension, delayed-release (containing enteric-coated granules)

40 mg (of pantoprazole) per packet

Protonix

Wyeth

Tablets, delayed-release (enteric-coated)

20 mg (of pantoprazole)

Protonix

Wyeth

40 mg (of pantoprazole)

Protonix

Wyeth

Parenteral

For injection, for IV infusion

40 mg (of pantoprazole)

Protonix I.V.

Wyeth

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Pantoprazole Sodium 20MG Enteric-coated Tablets (WYETH): 30/$15.99 or 90/$33.97

Pantoprazole Sodium 40MG Enteric-coated Tablets (WYETH): 30/$15.99 or 90/$33.99

Protonix 20MG Enteric-coated Tablets (WYETH): 30/$186.38 or 90/$559.13

Protonix 40MG Enteric-coated Tablets (WYETH): 30/$190.00 or 90/$529.99

Protonix 40MG Packet (WYETH): 30/$175.98 or 90/$499.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions February 13, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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6. Webb DD. New therapeutic options in the treatment of GERD and other acid-peptic disorders. Am J Managed Care. 2000; 6:S467-75.

7. Berardi RR. A critical evaluation of proton pump inhibitors in the treatment of gastroesophageal reflux disease. Am J Managed Care. 2000; 6:S491-505.

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9. Wyeth, St. Davids, PA: Personal communication.

10. Wyeth. Protonix (pantoprazole sodium) I.V. for injection prescribing information. Philadelphia, PA; 2007 Dec.

11. AstraZeneca. Nexium (esomeprazole magnesium) delayed-release capsules prescribing information. Wilmington, DE; 2001 Feb.

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14. Kentrup WA. Dear health care professional letter regarding breakage of Protonix IV glass vials with spiked IV adaptors. Philadelphia, PA: Wyeth; 2004 Aug.

15. Food and Drug Administration. Protonix IV (pantoprazole sodium) injection [September 24, 2004: Wyeth]. MedWatch. Rockville, MD; September 2004. From FDA website.

16. AstraZeneca. Nexium (esomeprazole magnesium) delayed-release capsules prescribing information. Wilmington, DE; 2003 Mar.

17. TAP. Prevacid (lansoprazole) delayed-release capsules, for delayed-release oral suspension and delayed-release orally disintegrating tablets prescribing information. Lake Forest, IL; 2003 Aug.

18. Freston JW. Review article: role of proton pump inhibitors in non-H. pylori-related ulcers. Aliment Pharmacol Ther. 20001; 15(Suppl 2):2-5.

19. Hanauer SB, Sandborn W, and the Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn’s disease in adults: Practice Guidelines. Am J Gastroenterol. 2001; 96:635-43. [IDIS 461432] [PubMed 11280528]

20. Valori RM, Cockel R. Omeprazole for duodenal ulceration in Crohn’s disease. Br Med J. 1990; 300:438-9.

21. Bianchi G, Ardizzone S, Petrillo M et al. Omeprazole for peptic ulcer in Crohn’s disease. Am J Gastroenterol. 1991; 86: 245-6. [PubMed 1992643]

22. Przemioslo RT, Mee AS. Omeprazole in possible esophageal Crohn’s disease. Dig Dis Sci. 1994; 39:1594-5. [IDIS 333053] [PubMed 8026276]

23. Dickinson JB. Is omeprazole helpful in inflammatory bowel disease? J Clin Gastroenterol. 1994; 18:317-9.

24. Abrahao LJ Jr., Abrahao LJ, Vargas C et al. [Gastoduodenal Crohn’s disease—report of 4 cases and review of the literature]. (Portuguese; with English abstract.) Arq Gastroenterol. 2001; 38:57-62.

25. Laheij RJF, Sturkenboom MCJM, Hassing RJ et al. Risk of community-acquired pneumonia and use of gastric acid-suppressive drugs. JAMA. 2004;292:1955-60.

26. Gregor JC. Acid suppression and pneumonia.; a clinical indication for rational prescribing. JAMA. 2004;292:2012-3. Editorial.

27. Yang Y-X, Lewis JD, Epstein S et al. Long-term proton pump inhibitor therapy and risk of hip fracture. JAMA. 2006; 296:2947-53. [PubMed 17190895]

28. Pratha V, Hogan DL, Lynn RB et al. Intravenous pantoprazole as initial treatment in patients with gastroesophageal reflux disease and a history of erosive esophagitis: a randomized clinical trial. Dig Dis Sci. 2006; 51:1595-601. [PubMed 16927137]

29. Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (Nov 3, 2008). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

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